Editor’s Note: This post is the final of three coinciding with GlobalSubmit’s 3-part Module 1 Education webinar series.
The inclusion of grouped submissions in the new Module 1 specification (DTD v3.3) is a major victory for industry. Themes that we’ve stressed throughout the Module 1 rollout like automation, efficiency, and modernization all apply here.
Grouped submissions are like the carbon copy feature we use every day when emailing business colleagues, friends, and family members. Imagine you’re sending out a document for review or a group dinner invitation; you obviously wouldn’t prepare dozens of individual emails containing the same message. All parties you wanted to contact would be entered into the Cc field for one to many communication.
A grouped submission eliminates the need to submit multiple, identical submissions to different applications. For example, a manufacturing part change might impact a dozen applications. In the age of grouped submissions, a new sequence would be created to note the part change, and that sequence would then point to all other applications affected.
Now it’s important to remember that grouped submissions are optional. If you want to take advantage of the time savings possible with grouped submissions, you must use the new M1 specifications.
Here are a few variables to consider when working with grouped submissions:
1. Only one application type (ex: NDA) can be used in a grouped submission
2. Only one submission type (ex: Labeling Supplement) can be used in a grouped submission
3. Grouped submissions are only supported using DTD version 3.3 or higher
4. Grouped submissions across CDER/CBER are not valid
5. Rejection for any reason will lead to rejection for all applications in the group
6. Submission can be “ungrouped” at any time by submitting files to a single application only
7. All submissions that are grouped will be migrated to DTD 3.3 and lifecycle must continue in 3.3.
In terms of practical application for grouped submissions, the Agency has published recommendations (see Table 1). However, at this year’s DIA eRegulatory and Intelligence conference, representatives of the FDA indicated that grouped submissions would evolve as sponsors invent creative and unexpected uses of the new functionality.
Structure of Grouped Submissions (True vs. False)
How exactly does the new M1 specification work behind the scenes to relate one submission to a host of applications?
Let’s start by resolutely stating that there is no such thing as a parent application as far as grouped submissions are concerned.
When a grouped submission is created, the physical files will only reside in one application. That application is considered the primary application and has a value of “true” for the application-containing-files attribute. When publishing out a grouped submission, the primary application is the application you would publish.
Any application the primary grouped submission points to would have a value of “false” for the application-containing-files attribute. Only one application contains physical files. When the FDA analyzes grouped submissions with a value of “false” they are referred to the database location of the physical files.
Technology for Grouped Submissions (Sponsor and Agency)
The FDA updated its submission review technology to account for grouped submissions, and industry will similarly experience a learning curve as the new M1 specifications take effect.
In our application wizard (Figure 4), we see the grouped submission 677222 (Application Number) 0000 (submission id) 0001 (sequence number). The submission in blue hyperlink text is part of the grouping. Reviewers at the FDA will be able to click and launch all grouped submissions from this vantage point.
From a sponsor perspective, you’ll need visibility as to which applications belong to a grouped submission. In GlobalSubmit REVIEW, a double folder icon denotes a grouped submission.
Finally, FDA guidance states that only 1 form is needed when submitting to multiple regulatory activities in a single application. Your eCTD publishing tool would display a number of forms as pictured in Figure 6. In the review tool, a user would only see the application form corresponding to sequence you’ve loaded (Figure 7).